Data / Federal rules / 2026-13140
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
The Food and Drug Administration published this final rule in the Federal Register on June 30, 2026. It took effect on June 30, 2026.
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What the agency says
The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the monitor for opioid induced impairment of oxygenation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Key facts
- Document number
- 2026-13140
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 30, 2026
- Takes effect
- June 30, 2026
- Dates
- This order is effective June 30, 2026. The classification was applicable on March 31, 2023.
- Docket
- Docket No. FDA-2026-N-6707
- Code of Federal Regulations
- 21 CFR 868
- Topics
- Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in June 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.